Thermo Fisher Scientific
Senior Scientist, Material Qualification & Release (QC GMP)(m/w/x)
Full-timeOn-siteSenior
Lengnau
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FIFisher Clinical Services GmbH
Lead QC Technician(m/w/x)
Lengnau
Full-timeOn-siteSenior
Nejo AI Summary
Product testing and inspection in a cGMP environment for life science solutions, leading a team of QC technicians. 4 years QC experience in regulated pharma/med device environment, with analytical testing equipment proficiency, required. Leadership role in critical quality function.
Requirements
- Minimum 4 years quality control experience in regulated environment (pharmaceutical/medical device preferred)
- Preferred fields of study: Chemistry, Biology, or related scientific field
- Proficiency with analytical testing equipment and techniques (HPLC, GC, spectrophotometry)
- Strong understanding of cGMP requirements and quality systems
- Experience with quality documentation and data review
- Ability to lead and mentor others while maintaining quality standards
- Excellent attention to detail and organizational skills
- Strong verbal and written communication abilities
- Proficiency with standard office software and LIMS systems
- Ability to work in cleanroom environments and follow gowning procedures
- Physical ability to stand for extended periods, lift up to 25 lbs occasionally
- Flexibility to work various shifts
- Problem-solving and technical troubleshooting skills
- Experience writing and reviewing SOPs and technical documentation
Tasks
- Conduct product testing and inspection in a cGMP environment.
- Coordinate quality control activities.
- Lead a team of QC technicians.
- Collaborate with cross-functional teams to maintain quality standards.
- Perform analytical testing.
- Document testing results.
- Support continuous improvement initiatives.
- Mentor team members.
- Organize daily MBQC laboratory operations.
- Maintain MBQC laboratory equipment and operations.
- Create and revise guidance documents like SOPs/WIs.
- Serve as Subject Matter Expert for Bioburden, Growth Promotion, Micro Identifications, and Endotoxin testing methods.
- Provide expertise on quality events related to these methods.
- Participate in microbiological method transfer, development, verification, and validation.
- Qualify equipment for microbiological analysis.
- Perform backup testing for final, intermediate, and in-process products.
- Perform backup testing for cleaning validation samples.
- Perform backup testing for utility and environmental monitoring samples.
- Support QC GMP inspection readiness to ensure document compliance.
- Support QC teams with material ordering, sample logistics, and inventory management.
- Act as Biosafety Officer at the Lengnau site, adhering to Swiss law.
Work Experience
- 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- HPLC
- GC
- spectrophotometry
- LIMS systems
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fisher Clinical Services GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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FIFisher Clinical Services GmbH
Lead QC Technician(m/w/x)
Lengnau
Full-timeOn-siteSenior
Nejo AI Summary
Product testing and inspection in a cGMP environment for life science solutions, leading a team of QC technicians. 4 years QC experience in regulated pharma/med device environment, with analytical testing equipment proficiency, required. Leadership role in critical quality function.
Requirements
- Minimum 4 years quality control experience in regulated environment (pharmaceutical/medical device preferred)
- Preferred fields of study: Chemistry, Biology, or related scientific field
- Proficiency with analytical testing equipment and techniques (HPLC, GC, spectrophotometry)
- Strong understanding of cGMP requirements and quality systems
- Experience with quality documentation and data review
- Ability to lead and mentor others while maintaining quality standards
- Excellent attention to detail and organizational skills
- Strong verbal and written communication abilities
- Proficiency with standard office software and LIMS systems
- Ability to work in cleanroom environments and follow gowning procedures
- Physical ability to stand for extended periods, lift up to 25 lbs occasionally
- Flexibility to work various shifts
- Problem-solving and technical troubleshooting skills
- Experience writing and reviewing SOPs and technical documentation
Tasks
- Conduct product testing and inspection in a cGMP environment.
- Coordinate quality control activities.
- Lead a team of QC technicians.
- Collaborate with cross-functional teams to maintain quality standards.
- Perform analytical testing.
- Document testing results.
- Support continuous improvement initiatives.
- Mentor team members.
- Organize daily MBQC laboratory operations.
- Maintain MBQC laboratory equipment and operations.
- Create and revise guidance documents like SOPs/WIs.
- Serve as Subject Matter Expert for Bioburden, Growth Promotion, Micro Identifications, and Endotoxin testing methods.
- Provide expertise on quality events related to these methods.
- Participate in microbiological method transfer, development, verification, and validation.
- Qualify equipment for microbiological analysis.
- Perform backup testing for final, intermediate, and in-process products.
- Perform backup testing for cleaning validation samples.
- Perform backup testing for utility and environmental monitoring samples.
- Support QC GMP inspection readiness to ensure document compliance.
- Support QC teams with material ordering, sample logistics, and inventory management.
- Act as Biosafety Officer at the Lengnau site, adhering to Swiss law.
Work Experience
- 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- HPLC
- GC
- spectrophotometry
- LIMS systems
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fisher Clinical Services GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Fisher Clinical Services GmbH
Industry
Science
Description
Das Unternehmen ist marktführend in den Bereichen Clinical Supply Chain Management Services und Clinical Supplies für Patienten weltweit.
Not a perfect match?
- Thermo Fisher Scientific
Senior Scientist, Material Qualification & Release (QC GMP)(m/w/x)
Full-timeOn-siteSeniorLengnau - Thermo Fisher Scientific
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Full-timeOn-siteSeniorLengnau - Thermo Fisher Scientific Inc.
Senior Requalification Engineer(m/w/x)
Full-timeOn-siteSeniorLengnau - SIEGFRIED DiNAMIQS AG
QA Specialist(m/w/x)
Full-timeOn-siteSeniorSchlieren